Pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) reassessed fingolimod (trade name: Gilenya), a drug for the treatment of adults with highly active relapsing remitting multiple sclerosis (RRMS). The Federal Joint Committee (G-BA) had limited its decision on the first assessment from 2012 to three years because it considered the certainty of the data as insufficient. This obliged the drug manufacturer to submit a second dossier.

It did not submit any new studies, but reanalysed studies that were already available. On this basis, IQWiG reached different conclusions: From the data, an added benefit was now derived for two instead of only one of a total of three patient groups. IQWiG now found an indication where it had found a hint before.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/fingolimod-in-rrms-indication-of-added-benefit-in-certain-patients.6738.html